Following a rough outing throughout much of this year, biopharmaceutical firm Inhibrx (NASDAQ:INBX) finally gave stakeholders reason to smile. Earlier today, the company announced it discussed with the Food and Drug Administration (FDA) matters associated with its key therapeutic INBRX-101. In turn, the FDA stated potential exists for Inhibrx to pursue accelerated approval in the U.S. As a result, INBX stock initially shot up 30% before swinging as high as 50% in the afternoon session.
Per the biopharma’s press release, INBRX-101 represents an optimized recombinant human AAT-Fc fusion protein. This treatment targets superior health outcomes for patients with emphysema due to alpha-1 antitrypsin deficiency (AATD).
INBRX-101 uses functional alpha-1 antitrypsin, or AAT, serum levels as the surrogate endpoint. As well, Inhibrx announced the detection of INBRX-101 in the bronchoalveolar lavage fluid (BALF) samples from all AATD patients tested in the Phase 1 study.
According to MarketWatch, Inhibrx “plans to initiate in the first quarter of 2023 a potential registration-enabling clinical trial using functional AAT as a surrogate endpoint with the intent to submit for regulatory approval under the FDA’s accelerated approval program.”
Notably, management stated that the FDA expressed willingness to collaborate with Inhibrx “to address the regulatory challenges associated with AATD drug development.” Specifically, the FDA “emphasized the importance of being able to demonstrate INBRX-101’s ability to maintain a trough level within the normal range of AAT in healthy individuals.”
INBX Stock Tempts Onlookers, But Obstacles Remain
Based on clinical trial data associated with the aforementioned Phase 1 study, “the dosing of INBRX-101 every three or four weeks in patients with AATD is predicted to maintain patients above the lower threshold of the normal range and achieve an average level of functional AAT that approximates that of healthy non-deficient (MM genotype) adults.” That’s the good news for INBX stock in terms of longer-term sustainability.
However, the underlying recombinant protein technology presents significant challenges. Per a research article, “Fusion protein technologies for biopharmaceuticals: Applications and challenges,” the authors point out intrinsic challenges exist. These include “immunogenicity that may occur due to the formation of novel epitopes at the junction between the fusion partners even if fully human proteins are connected.”
As well, roadblocks drag on design, engineering and prerequisites associated with effective recombinant protein-based therapeutics. Not insignificantly, despite INBX stock skyrocketing on Tuesday, it remains about 30% below parity on a year-to-date basis.
On the date of publication, Josh Enomoto did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.